Boston Scientific has signed an agreement worth up to $300m to acquire Apama Medical and its radiofrequency (RF) balloon catheter system designed for the treatment of a common heart rhythm disorder called atrial fibrillation (AF).
Affecting more than 33 million people across the world, AF is commonly treated with anti-arrhythmic drugs and cardiac ablation, which is a process where energy is delivered to the areas of the heart muscle causing an abnormal rhythm.
The agreement includes an initial upfront cash payment of $175m from Boston and an additional $125m in contingent payments between 2018 and 2020 based on clinical and regulatory milestones.
Subject to customary closing conditions, the deal is expected to close during the fourth quarter of this year.
Apama’s new RF balloon is a single-shot, multi-electrode device designed to combine the benefits of RF point-by-point and balloon-based ablation approaches.
The company claims that the system has the ability to deliver differentiated energy levels and shorter procedure times.
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Boston Scientific Rhythm Management president Joe Fitzgerald said: “The acquisition of Apama further advances our continued investment in the electrophysiology category, and, upon commercialisation, would broaden our portfolio of differentiated arrhythmia solutions.
“We are also excited about the ability to integrate the Apama RF balloon system with our RHYTHMIA HDx Mapping System to provide physicians with an unprecedented visualisation of the heart during ablation procedures.”
According to Apama, initial results from a first-in-human study, AF-FICIENT, showed that the RF balloon met the safety and efficacy study endpoints, achieving successful PVI in patients with paroxysmal AF.
Boston Scientific Rhythm Management and Global Health Policy senior vice-president and chief medical officer Kenneth Stein said: “Study results reinforce the Apama RF balloon in an advancement in single-shot technology for PVI and can provide physicians with greater control and efficiency when performing AF ablations.”
The RF balloon is currently being evaluated in clinical trials in Europe to serve as the basis for CE-Mark approval, which is expected late next year.